EUCTR2016-005129-35-IT进行中（未招募）1 期
Peptide Receptor Radionuclide Therapy (PRRT) with somatostatin analogs in tumors over-expressing somatostatin receptors - PRRT in tumours over-expressing somatostatin receptors
AZIENDA OSPEDALIERO UNIVERSITARIA DI FERRARA0 个研究点目标入组 250 人开始时间: 2021年6月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years, of both sexes, of any ethnicity;
- •2. Hhistological and immunohistochemical diagnosis of NET;
- •3. Evaluation of the cell proliferation index by study of Ki-67 and/or MIB-1.
- •4. Disease measurable according to the RECIST 1.1 criteria by conventional imaging (TC with MDC or MRI with MDC) not before the two months of enlistment;
- •5. High expression of somatostatin receptors documented by PET-TC with 68Ga-DOTATOC in the target lesion (s). It is defined as high expression of the receptors for Somatostatin a report of SUVmax lesion/SUVmean muscle = 4:1 calculated with semi-quantitative analysis at the PET-TC examination with 68Ga-dotatoc;
- •6. Dosage of Chromogranin A (and any other specific markers) not prior to two months of enrolment;
- •7. Evaluation of glucose metabolism in the target lesion (s) by PET-TC with 18F-FDG;
- •8. Conserved haematological, hepatic and renal parameters, in particular:
- •-White blood cells = 2500/µl
- •-platelets = 90000/µl
- •-hemoglobin = 9 gr/dl
- •-creatinine = 2 mg/dl
- •-bilirubin = 2.5 mg/dl
- •9. ECOG performance status = 2;
- •10. Life expectancy = 6 months;
- •11. Stable or progressive disease, at any stage, in both operable and non-operable patients;
- •12. Absence of standard treatments already documented and of equal efficacy;
- •13. No surgical treatment, chemotherapy and/or radiation for at least 30 days. On the other hand, patients in therapy with somatostatin analogues or biological drugs (e.g. m-tor inhibitors) may be considered to be enrolled;
- •14. Voluntary accession to the study by signing the informed consent form, after reading and complete understanding of the information notes.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Lack of the requirements listed above;
- •2. Pregnancy status;
- •3. Breastfeeding and its refusal to suspend breastfeeding;
- •4. Participation in another therapeutic experimental clinical protocol in the four weeks preceding PRRT;
- •5. Ensured medullary disease invasion > 25%;
- •6. Extended Radiation treatments (emibody).
研究者
相似试验
进行中（未招募）
不适用
Peptide Receptor Radionuclide Therapy (PRRT) in advanced gastro-entero-pancreatic Neuroendocrine TumorsAdvanced gastro-entero-pancreatic Neuroendocrine Tumors, FDG-PET negative patientsMedDRA version: 16.0Level: HLGTClassification code 10014713Term: Endocrine neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003165-34-ITIRCCS-IRST of Meldola
已完成
不适用
Peptide receptor radionuclide therapy (PRRT) in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET) - Evaluation of treatment response and hemato- and nephrotoxicityGastroenteropancreatic neuroendocrine Tumors.C15-C26Malignant neoplasms of digestive organsDRKS00008976niversitätsklinikum Freiburg63
尚未招募
不适用
se of peptide receptor radionuclide therapy (PRRT) in neuroendocrine tumour (NET) patients in Germany – A retrospective evaluation in German centers for NETConfirmed diagnosis of GEP-NET (any localization of the primary tumour including CUP , any Grade)DRKS00031054ovartis Radiopharmaceuticals GmbH100
终止
1 期
Peptide Receptor Radionuclide Therapy administered to Participants withMeningioma with 67Cu-SARTATE™Cancer - BrainCancer - Head and neckCancer - Other cancer typesMeningiomaACTRN12618000309280Clarity Pharmaceuticals Ltd.5
招募中
不适用
Improving Peptide Receptor Radionuclide Therapy with PARP inhibitors.well-differentiated advanced gastroenteropancreatic neuro-endocrine tumors.NL-OMON21221Erasmus MC, Rotterdam, the Netherland24